Operational Product Compliance Expert

Mission

IBA Technologies (an entity of IBA) is willing to reinforce its practice and processes related to its existing and future products, towards more efficiency and compliance reinforcement. As a consequence, we are now looking for a pragmatic technical expert with the drive to make things happen.
Our Operational Product Compliance Expert position is located in Louvain-la-Neuve within the Quality department of the IBA Technologies entity and will require close collaboration with all IBA Business Units.

Challenges we trust you with

• Support R&D experts and product management teams of IBA Radiopharma Solutions (RPS) and IBA Industrial Solutions (Indus) with their product compliance:
  • Supporting the development of the product compliance roadmap
  • Analysing technical standards applicability, performing gap assessment and impact analysis on RPS and Indus products
  • Finding the right balance between traceability to standards and testing methodology and overall cost to the company
  • Supporting implementation and evolution of digital tools to achieve this purpose
  • Identifying external partners such as testing labs and be their main contact point
• Explore the needs and support implementation of product compliance for future applications 
• Lead the Product Compliance Steering Committee for IBA Technologies
• Interface and coordinate activities with the IBA Clinical entity through: 
  • Representing IBA Technologies in joint product compliance efforts with IBA Clinical 
  • Driving high level alignment, convergences and synergies of compliance roadmaps 
  • Follow-up compliance proactive and corrective (post-audit) actions

What we value

You have:

• Master degree in a technical field (science, engineering…)
• 5+ year experience in project management in a regulated environment
• Experience in achieving product and process compliance, e.g. using technical standards as a support
• Experience in specifying and setting up modern traceability tools (e.g. Siemens Polarion)
• Communication and plan follow-up in JIRA and Confluence is an asset
• Specific knowledge in Electromechanical Systems/Machinery is another asset, e.g. in the domain of electromagnetic compatibility, electrical safety
• Excellent communication skills and can adapt your message to your audience
• French and English are required

And you also are:

• Able to organize your work autonomously and take initiatives
• Curious, you care for other’s needs and are willing to anticipate these
• Problem-solving oriented
• A team player having the passion to listen, understand, communicate and positively impact the business